Strongbridge Biopharma Announces Issuance of U.S. Patent for Investigational COR-003 (levoketoconazole) in Treatment of Endogenous Cushing's Syndrome

DUBLIN, Ireland and TREVOSE, Pa., Dec. 7, 2015 (GLOBE NEWSWIRE) -- Strongbridge Biopharma plc (Nasdaq:SBBP) today announced that the United States Patent and Trademark Office (USPTO) issued a patent related to the Company's lead investigational drug candidate, COR-003 (levoketoconazole), a cortisol inhibitor that is currently being studied in a global Phase 3 trial for the treatment of endogenous Cushing's syndrome.

The claims of U.S. Patent No. 9,198,906 are directed towards methods of reducing C-reactive protein (CRP) levels and systemic inflammation through administration of a once-daily dose of levoketoconazole.

"This patent is an important step forward in our research efforts in Cushing's syndrome and for our lead investigational drug candidate, COR-003," said Matthew Pauls, president and chief executive officer of Strongbridge Biopharma. "Our Phase 3 trial is designed to evaluate the overall safety and efficacy of COR-003 in patients with elevated levels of cortisol due to endogenous Cushing's syndrome. We look forward to evaluating the key secondary endpoint data related to the potential benefits of reducing CRP levels and systemic inflammation in this patient population," Pauls added.

About Strongbridge Biopharma

Strongbridge Biopharma's strategic focus is to build a biopharmaceutical company focused on the development, in-licensing, acquisition and eventual commercialization of complementary product candidates across multiple franchises that target rare diseases. Strongbridge Biopharma's lead product candidate, COR-003 (levoketoconazole), is a cortisol inhibitor that is currently being studied in the global Phase 3 trial for the treatment of endogenous Cushing's syndrome. Strongbridge Biopharma recently expanded its rare endocrine disease franchise with the completion of transactions for two Phase 2 product candidates: COR-004, a novel second-generation antisense compound, which is in clinical development for the treatment of acromegaly and designed to block the synthesis of growth hormone receptor (GHr), thereby reducing levels of insulin-like growth factor-1 (IGF-1) in the blood; and COR-005, a next-generation somatostatin analog (SSA) with a unique receptor affinity profile, being investigated for the treatment of acromegaly, with potential additional applications in Cushing's disease and neuroendocrine tumors. COR-003 and COR-005 have received orphan designation from both the European Medicines Agency and the U.S. Food and Drug Administration, and the Company is pursuing orphan designation for COR-004. Strongbridge Biopharma's intent is to independently commercialize its rare endocrine assets in key global markets.

Forward-Looking Statements

This press release contains forward-looking statements that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release, are forward-looking statements. These statements relate to future events and involve known and unknown risks, including, without limitation, uncertainties regarding Strongbridge's strategy, plans, intellectual property rights, outcomes of product development efforts and objectives of management for future operations. The words "anticipate," "estimate," "expect," "intend," "may," "plan," "potential," "project," "target," "will," "would," or the negative of these terms or other similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements are based on current expectations, estimates, forecasts and projections and are not guarantees of future performance or development and involve known and unknown risks, uncertainties and other factors. The forward-looking statements contained in this press release are made as of the date of this press release, and Strongbridge Biopharma does not assume any obligation to update any forward-looking statements except as required by applicable law.

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